K013120

Substantially Equivalent

PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18

Applicant: Medamicus, Inc.
Product code: GZB
Advisory panel: Neurology
Date received: 2001-09-18
Decision date: 2002-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Adverse events under product code GZB

product code GZB

Death: 4
Injury: 1,879
Other: 2
Total: 1,885

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.